Q. What is EU MDR, exactly?
A. The EU MDR details rules and regulations to which any medical device manufacturer intending to distribute to the EU must comply. The EU MDR is an enhancement of the previous EU Medical Device Directive (MDD) from 1993. A universal database (EUDAMED) has been created to serve as a repository for all approved devices.
Q. Why is EU MDR being implemented?
A. The aging population is driving the development of new medical devices in the market. Some devices are being reclassified, and other previously unrecognized accessory devices, such as sterilization equipment, are now considered medical devices. There are legacy devices that will have to either meet the new standards or be obsoleted out by OEMs, likely based on cost. There is also an increase in the number of member states within the EU as well as a multitude of different spoken languages.
Patient safety is the #1 priority and, as such, emphasis is being placed on the need for biological evaluations (ISO 10993-1), including risk assessments, quality and material management, clinical evaluations, human risk factors and post market surveillance.
Q. What information will be required on medical device labels?
MDR requires a Unique Device Identifier (UDI) label be attached to a medical device and/or to its packaging. The UDI is the essential track and trace mechanism that links directly to the EUDAMED database. The UDI label is necessary to track and trace all devices throughout the supply chain and/or lifecycle and is an important element should a recall happen.
The information contained within the UDI include:
- name of manufacturer
- device family
- specific product identification including lot and serial number, date of manufacture, and expiration date
The manufacturer website must be noted either on the product label or within the packaging materials. The website must be kept up to date with product information, such as data sheets and alerts regarding safety, corrective action and recalls.
Additionally, because there are 24 different languages spoken in the EU, the use of uniformly recognizable symbols will be required on labels and inserts. Some examples are:
Q. Where will the information live and who is responsible for reporting it?
A. The information for each medical device will reside in a single repository, the EUDAMED, a device registry website. Once a medical device product is completed through the production cycle and approved by the notified body, it will need to be registered in the EUDAMED database. Devices can be searched in the database for product information, intended use and instructions, as well as searched in the event of a recall.
Q. What does this mean for label printers?
A. Manufacturing must take 100% responsibility for up-front evaluation in the product design phase for all intended materials used in the manufacture of the final device. This includes the labels. Therefore, it is imperative that label converters who have customers selling medical devices into Europe are prepared.
The good news? Additional and/or larger labels, as well as multi-lingual leaflets, may be required on devices moving forward, so there is potential for increased volume with the existing customer base.
Label converters can get ready by educating themselves about the regulations, including required messaging, and ensuring that the print media being brought in is robust and durable to meet the requirements for UDI labeling. The label material must remain intact, legible, and able to withstand the environmental and application use for the life of the device. Material selection for labeling, including the ink and print method are critical considering the importance as it pertains to this new MDR.
